A Phase I/II Study to Assess the Safety and Therapeutic Effect of INCB007839 in Combination With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer.
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Incyte Corporation
- Enrollment
- 20
- Primary Endpoint
- Evaluation of safety and tolerabilty as determined by monitoring the frequency and severity of adverse events (AEs) and performing clinical assessments and laboratory investigations.
Study Overview
Brief Summary
This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839 in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer
- •Subject with histological HER2+ status as determined by FISH with a gene amplification score of ≥ 2.2
- •Subject with availability of archival biopsy tissue from primary tumor or metastatic lesions
- •Subject with presence of measurable disease based on RECIST 1.1
- •Subject who has received no more than three prior HER2-directed therapeutic regimens for advanced breast cancer
Exclusion Criteria
- •Subject with Left ventricular ejection fraction (LVEF) below institutional normal range
- •Subject with metastasis to the central nervous system UNLESS asymptomatic and clinically stable
- •Subject with current active malignancy other than breast cancer
- •Subject with prior history of other malignancy except for cancers from which the patient is currently disease free
- •Subject with significant renal or hepatic dysfunction
- •Subject with history of venous or arterial thrombosis or risk factor for thrombosis other than history of malignancy
- •Subject with insufficient bone marrow function
- •Subject with contraindication to vinorelbine, trastuzumab, aspirin and/or warfarin therapy.
- •Subject with current active bacterial, Hepatitis B or C, and/or HIV infections
Arms & Interventions
Treatment A - INCB007839 300mg BID
This is a single arm, open label study in which all patients will receive a single dose of the investigational product INCB007839 in combination with a standard regimen of trastuzumab and vinorelbine.
Intervention: INCB007839 300mg BID (Drug)
Treatment A - INCB007839 300mg BID
This is a single arm, open label study in which all patients will receive a single dose of the investigational product INCB007839 in combination with a standard regimen of trastuzumab and vinorelbine.
Intervention: Trastuzumab (Drug)
Treatment A - INCB007839 300mg BID
This is a single arm, open label study in which all patients will receive a single dose of the investigational product INCB007839 in combination with a standard regimen of trastuzumab and vinorelbine.
Intervention: Vinorelbine (Drug)
Outcomes
Primary Outcomes
Evaluation of safety and tolerabilty as determined by monitoring the frequency and severity of adverse events (AEs) and performing clinical assessments and laboratory investigations.
Time Frame: Measured monthly starting at Baseline (estimated duration 6-9 months)
Secondary Outcomes
- Overall objective response rate assessed by RECIST criteria(Measured at Baseline, Cycle 4 and approximately every 9 weeks after (estimated duration 6-9 months))